Standardizing, harmonizing, and protecting data collection to broaden the impact of COVID-19 research: the rapid acceleration of diagnostics-underserved populations (RADx-UP) initiative.

Objective: The Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program is a consortium of community-engaged research projects with the goal of increasing access to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) tests in underserved populations. To accelerate clinical research, common data elements (CDEs) were selected and refined to standardize data collection and enhance cross-consortium analysis.

Materials And Methods: The RADx-UP consortium began with more than 700 CDEs from the National Institutes of Health (NIH) CDE Repository, Disaster Research Response (DR2) guidelines, and the PHENotypes and eXposures (PhenX) Toolkit.

Improving and sustaining the site investigator community: Recommendations from the Clinical Trials Transformation Initiative.

The Clinical Trials Transformation Initiative (CTTI) Strengthening the Investigator Community Project was prompted by the need to understand the reasons for high rates of turnover among investigators who lead US Food and Administration-regulated clinical trials at research sites. Because investigator knowledge and experience directly affect the quality and ultimate success of clinical trials, investigator turnover has important implications for the research enterprise, as well as the patients and other stakeholders who depend on the outcomes of clinical research. The CTTI project team used findings from both quantitative and qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to delineate key concerns faced by investigators and recommend practical, action-based solutions.

Evaluating Foundational Data Quality in the National Patient-Centered Clinical Research Network (PCORnet®).

Introduction: Distributed research networks (DRNs) are critical components of the strategic roadmaps for the National Institutes of Health and the Food and Drug Administration as they work to move toward large-scale systems of evidence generation. The National Patient-Centered Clinical Research Network (PCORnet®) is one of the first DRNs to incorporate electronic health record data from multiple domains on a national scale. Before conducting analyses in a DRN, it is important to assess the quality and characteristics of the data.

Compliance with results reporting at ClinicalTrials.gov.

Background: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results.

Effects of exercise training amount on physical activity energy expenditure.

Introduction: We examined the effects of three exercise training interventions on total physical activity energy expenditure (PAEE) or nonexercise PAEE in a randomized controlled trial where sedentary, overweight, and obese men and women were assigned to inactive control, low-amount/moderate-intensity, low-amount/vigorous-intensity, or high-amount/vigorous-intensity aerobic exercise.

Methods: To measure PAEE, triaxial RT3 accelerometers were worn by subjects for 7 d at the beginning and end of an 8-month exercise intervention. In total, 50 subjects (control, n = 8; two low-amount groups, n = 28; high-amount group, n = 14) had usable PAEE data collected at both time points.